Label: SOOTHION ANTISEPTIC HAND SANITIZER- benzalkonium chlroide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 2, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    When using this product

    avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation and redness develops
    • condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately. For children under 6, only use under adult supervision.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other information

    • Store in a cool, dry place below 77°F
    • Protect from heat and light


  • Inactive ingredients

    Water, Calendula Oil, Fragrance Oil, Thyme Oil, Tea Tree Oil, Polyacrylic Acid
  • DESCRIPTION

    Questions? Call:

    1-866-528-3721 ex. 210.



    Mon-Fri 9AM to 5PM CST



    Manufactured For

    Electrolyzed Innovations, LLC
    1747 Commerce Dr. P.O Box 1499

    Piqua, OH 45356


  • Principal Display Panel

    FDA NDC # 69031-006-08

    Alcohol Free

    Antiseptic Gel Hand Sanitizer

    Soothion

    Non Dyring Formula Will Leave Your Hands Soft and Smooth

    Kills 99.9% of Common Germs

    Ion Dispersion Technology

    Enhanced with Quality Essential Oils

    8 fl oz (236 mL)

    PDP

  • INGREDIENTS AND APPEARANCE
    SOOTHION ANTISEPTIC HAND SANITIZER 
    benzalkonium chlroide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69031-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    THYME OIL (UNII: 2UK410MY6B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69031-006-08226 g in 1 BOTTLE; Type 0: Not a Combination Product03/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2015
    Labeler - Electrolyzed Innovations, LLC (079168827)
    Establishment
    NameAddressID/FEIBusiness Operations
    TropiChem Research Labs, Inc.603123068manufacture(69031-006)
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